Tags

Type your tag names separated by a space and hit enter

CoQ10 in progressive supranuclear palsy: A randomized, placebo-controlled, double-blind trial.
Neurol Neuroimmunol Neuroinflamm. 2016 Oct; 3(5):e266.NN

Abstract

OBJECTIVE

An investigator-initiated, multicenter, randomized, placebo-controlled, double-blind clinical trial to determine whether coenzyme Q10 (CoQ10) is safe, well tolerated, and effective in slowing functional decline in progressive supranuclear palsy (PSP).

METHODS

Sixty-one participants received CoQ10 (2,400 mg/d) or placebo for up to 12 months. Progressive Supranuclear Palsy Rating Scale (PSPRS), Unified Parkinson's Disease Rating Scale, activities of daily living, Mini-Mental State Examination, the 39-item Parkinson's Disease Questionnaire, and 36-item Short Form Health Survey were monitored at baseline and months 3, 6, 9, and 12. The safety profile of CoQ10 was determined by adverse events, vital signs, and clinical laboratory values. Primary outcome measures were changes in PSPRS and Unified Parkinson's Disease Rating Scale scores from baseline to month 12.

RESULTS

CoQ10 was well tolerated. No statistically significant differences were noted between CoQ10 and placebo groups in primary or secondary outcome measures. A nonsignificant difference toward slower clinical decline in the CoQ10 group was observed in total PSPRS among those participants who completed the trial. Before the final study visit at 12 months, 41% of participants withdrew because of travel distance, lack of perceived benefit, comorbidities, or caregiver issues.

CONCLUSIONS

High doses of CoQ10 did not significantly improve PSP symptoms or disease progression. The high withdrawal rate emphasizes the difficulty of conducting clinical trials in patients with PSP.

CLINICALTRIALSGOV IDENTIFIER

NCT00382824.

CLASSIFICATION OF EVIDENCE

This study provides Class II evidence that CoQ10 does not significantly slow functional decline in PSP. The study lacks the precision to exclude a moderate benefit of CoQ10.

Authors+Show Affiliations

Department of Neurology (D.A., S.A.S.), Lahey Hospital & Medical Center, Burlington, MA; Department of Neurology and Neurobiology (D.G.S., T.A.Y.), University of Alabama Hospital, Birmingham; Department of Neurology (R.W.H.), University of Vermont College of Medicine, Burlington; Department of Neurology (D.K.S.), Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA; and Research Design Center/Biostatistics Research Center (S.P., R.R.), Tufts Clinical & Translational Science Institute, Boston, MA.Department of Neurology (D.A., S.A.S.), Lahey Hospital & Medical Center, Burlington, MA; Department of Neurology and Neurobiology (D.G.S., T.A.Y.), University of Alabama Hospital, Birmingham; Department of Neurology (R.W.H.), University of Vermont College of Medicine, Burlington; Department of Neurology (D.K.S.), Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA; and Research Design Center/Biostatistics Research Center (S.P., R.R.), Tufts Clinical & Translational Science Institute, Boston, MA.Department of Neurology (D.A., S.A.S.), Lahey Hospital & Medical Center, Burlington, MA; Department of Neurology and Neurobiology (D.G.S., T.A.Y.), University of Alabama Hospital, Birmingham; Department of Neurology (R.W.H.), University of Vermont College of Medicine, Burlington; Department of Neurology (D.K.S.), Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA; and Research Design Center/Biostatistics Research Center (S.P., R.R.), Tufts Clinical & Translational Science Institute, Boston, MA.Department of Neurology (D.A., S.A.S.), Lahey Hospital & Medical Center, Burlington, MA; Department of Neurology and Neurobiology (D.G.S., T.A.Y.), University of Alabama Hospital, Birmingham; Department of Neurology (R.W.H.), University of Vermont College of Medicine, Burlington; Department of Neurology (D.K.S.), Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA; and Research Design Center/Biostatistics Research Center (S.P., R.R.), Tufts Clinical & Translational Science Institute, Boston, MA.Department of Neurology (D.A., S.A.S.), Lahey Hospital & Medical Center, Burlington, MA; Department of Neurology and Neurobiology (D.G.S., T.A.Y.), University of Alabama Hospital, Birmingham; Department of Neurology (R.W.H.), University of Vermont College of Medicine, Burlington; Department of Neurology (D.K.S.), Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA; and Research Design Center/Biostatistics Research Center (S.P., R.R.), Tufts Clinical & Translational Science Institute, Boston, MA.Department of Neurology (D.A., S.A.S.), Lahey Hospital & Medical Center, Burlington, MA; Department of Neurology and Neurobiology (D.G.S., T.A.Y.), University of Alabama Hospital, Birmingham; Department of Neurology (R.W.H.), University of Vermont College of Medicine, Burlington; Department of Neurology (D.K.S.), Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA; and Research Design Center/Biostatistics Research Center (S.P., R.R.), Tufts Clinical & Translational Science Institute, Boston, MA.Department of Neurology (D.A., S.A.S.), Lahey Hospital & Medical Center, Burlington, MA; Department of Neurology and Neurobiology (D.G.S., T.A.Y.), University of Alabama Hospital, Birmingham; Department of Neurology (R.W.H.), University of Vermont College of Medicine, Burlington; Department of Neurology (D.K.S.), Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA; and Research Design Center/Biostatistics Research Center (S.P., R.R.), Tufts Clinical & Translational Science Institute, Boston, MA.Department of Neurology (D.A., S.A.S.), Lahey Hospital & Medical Center, Burlington, MA; Department of Neurology and Neurobiology (D.G.S., T.A.Y.), University of Alabama Hospital, Birmingham; Department of Neurology (R.W.H.), University of Vermont College of Medicine, Burlington; Department of Neurology (D.K.S.), Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA; and Research Design Center/Biostatistics Research Center (S.P., R.R.), Tufts Clinical & Translational Science Institute, Boston, MA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27583276

Citation

Apetauerova, Diana, et al. "CoQ10 in Progressive Supranuclear Palsy: a Randomized, Placebo-controlled, Double-blind Trial." Neurology(R) Neuroimmunology & Neuroinflammation, vol. 3, no. 5, 2016, pp. e266.
Apetauerova D, Scala SA, Hamill RW, et al. CoQ10 in progressive supranuclear palsy: A randomized, placebo-controlled, double-blind trial. Neurol Neuroimmunol Neuroinflamm. 2016;3(5):e266.
Apetauerova, D., Scala, S. A., Hamill, R. W., Simon, D. K., Pathak, S., Ruthazer, R., Standaert, D. G., & Yacoubian, T. A. (2016). CoQ10 in progressive supranuclear palsy: A randomized, placebo-controlled, double-blind trial. Neurology(R) Neuroimmunology & Neuroinflammation, 3(5), e266. https://doi.org/10.1212/NXI.0000000000000266
Apetauerova D, et al. CoQ10 in Progressive Supranuclear Palsy: a Randomized, Placebo-controlled, Double-blind Trial. Neurol Neuroimmunol Neuroinflamm. 2016;3(5):e266. PubMed PMID: 27583276.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - CoQ10 in progressive supranuclear palsy: A randomized, placebo-controlled, double-blind trial. AU - Apetauerova,Diana, AU - Scala,Stephanie A, AU - Hamill,Robert W, AU - Simon,David K, AU - Pathak,Subash, AU - Ruthazer,Robin, AU - Standaert,David G, AU - Yacoubian,Talene A, Y1 - 2016/08/02/ PY - 2015/12/10/received PY - 2016/06/15/accepted PY - 2016/9/2/entrez PY - 2016/9/2/pubmed PY - 2016/9/2/medline SP - e266 EP - e266 JF - Neurology(R) neuroimmunology & neuroinflammation JO - Neurol Neuroimmunol Neuroinflamm VL - 3 IS - 5 N2 - OBJECTIVE: An investigator-initiated, multicenter, randomized, placebo-controlled, double-blind clinical trial to determine whether coenzyme Q10 (CoQ10) is safe, well tolerated, and effective in slowing functional decline in progressive supranuclear palsy (PSP). METHODS: Sixty-one participants received CoQ10 (2,400 mg/d) or placebo for up to 12 months. Progressive Supranuclear Palsy Rating Scale (PSPRS), Unified Parkinson's Disease Rating Scale, activities of daily living, Mini-Mental State Examination, the 39-item Parkinson's Disease Questionnaire, and 36-item Short Form Health Survey were monitored at baseline and months 3, 6, 9, and 12. The safety profile of CoQ10 was determined by adverse events, vital signs, and clinical laboratory values. Primary outcome measures were changes in PSPRS and Unified Parkinson's Disease Rating Scale scores from baseline to month 12. RESULTS: CoQ10 was well tolerated. No statistically significant differences were noted between CoQ10 and placebo groups in primary or secondary outcome measures. A nonsignificant difference toward slower clinical decline in the CoQ10 group was observed in total PSPRS among those participants who completed the trial. Before the final study visit at 12 months, 41% of participants withdrew because of travel distance, lack of perceived benefit, comorbidities, or caregiver issues. CONCLUSIONS: High doses of CoQ10 did not significantly improve PSP symptoms or disease progression. The high withdrawal rate emphasizes the difficulty of conducting clinical trials in patients with PSP. CLINICALTRIALSGOV IDENTIFIER: NCT00382824. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that CoQ10 does not significantly slow functional decline in PSP. The study lacks the precision to exclude a moderate benefit of CoQ10. SN - 2332-7812 UR - https://www.unboundmedicine.com/medline/citation/27583276/CoQ10_in_progressive_supranuclear_palsy:_A_randomized_placebo_controlled_double_blind_trial_ L2 - http://nn.neurology.org/cgi/pmidlookup?view=long&pmid=27583276 DB - PRIME DP - Unbound Medicine ER -