A Randomized Controlled Exploratory Pilot Study to Evaluate the Effect of Rotigotine Transdermal Patch on Parkinson's Disease-Associated Chronic Pain.
Identifieur interne : 000375 ( Main/Exploration ); précédent : 000374; suivant : 000376A Randomized Controlled Exploratory Pilot Study to Evaluate the Effect of Rotigotine Transdermal Patch on Parkinson's Disease-Associated Chronic Pain.
Auteurs : Olivier Rascol [France] ; Theresa Zesiewicz [États-Unis] ; K Ray Chaudhuri [Royaume-Uni] ; Mahnaz Asgharnejad [États-Unis] ; Erwin Surmann [Allemagne] ; Elisabeth Dohin [Belgique] ; Sigrid Nilius [Allemagne] ; Lars Bauer [Allemagne]Source :
- Journal of clinical pharmacology [ 1552-4604 ] ; 2016.
Abstract
Pain is a troublesome nonmotor symptom of Parkinson's disease (PD). This double-blind exploratory pilot study (NCT01744496) was the first to specifically investigate the effect of a dopamine agonist on PD-associated pain as primary outcome. Patients with advanced PD (ie, receiving levodopa) and at least moderate PD-associated chronic pain (≥3 months, ≥4 points on 11-point Likert pain scale) were randomized to rotigotine (optimal/maximum dose ≤16 mg/24h) or placebo and maintained for 12 weeks. Primary efficacy variable was change in pain severity (Likert pain scale) from baseline to end of maintenance. Secondary variables included percentage of responders (≥2-point Likert pain scale reduction), King's PD Pain Scale (KPPS) domains, and PD Questionnaire (PDQ-8). Statistical analyses were exploratory. Of 68 randomized patients, 60 (rotigotine, 30; placebo, 30) were evaluable for efficacy. A numerical improvement in pain was observed in favor of rotigotine (Likert pain scale: least-squares mean [95%CI] treatment difference, -0.76 [-1.87 to 0.34]; P = .172), and proportion of responders was 18/30 (60%) rotigotine vs 14/30 (47%) placebo. An ∼2-fold numerical improvement in KPPS domain "fluctuation-related pain" was observed with rotigotine vs placebo. Rotigotine improved PDQ-8 vs placebo (-8.01 [-15.56 to -0.46]; P = .038). These results suggest rotigotine may improve PD-associated pain; a large-scale confirmatory study is needed.
DOI: 10.1002/jcph.678
PubMed: 26626320
Affiliations:
- Allemagne, Belgique, France, Royaume-Uni, États-Unis
- Angleterre, Caroline du Nord, Floride, Grand Londres, Midi-Pyrénées, Occitanie (région administrative), Région de Bruxelles-Capitale
- Bruxelles, Londres, Toulouse
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This double-blind exploratory pilot study (NCT01744496) was the first to specifically investigate the effect of a dopamine agonist on PD-associated pain as primary outcome. Patients with advanced PD (ie, receiving levodopa) and at least moderate PD-associated chronic pain (≥3 months, ≥4 points on 11-point Likert pain scale) were randomized to rotigotine (optimal/maximum dose ≤16 mg/24h) or placebo and maintained for 12 weeks. Primary efficacy variable was change in pain severity (Likert pain scale) from baseline to end of maintenance. Secondary variables included percentage of responders (≥2-point Likert pain scale reduction), King's PD Pain Scale (KPPS) domains, and PD Questionnaire (PDQ-8). Statistical analyses were exploratory. Of 68 randomized patients, 60 (rotigotine, 30; placebo, 30) were evaluable for efficacy. A numerical improvement in pain was observed in favor of rotigotine (Likert pain scale: least-squares mean [95%CI] treatment difference, -0.76 [-1.87 to 0.34]; P = .172), and proportion of responders was 18/30 (60%) rotigotine vs 14/30 (47%) placebo. An ∼2-fold numerical improvement in KPPS domain "fluctuation-related pain" was observed with rotigotine vs placebo. Rotigotine improved PDQ-8 vs placebo (-8.01 [-15.56 to -0.46]; P = .038). These results suggest rotigotine may improve PD-associated pain; a large-scale confirmatory study is needed.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Belgique</li><li>France</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Caroline du Nord</li><li>Floride</li><li>Grand Londres</li><li>Midi-Pyrénées</li><li>Occitanie (région administrative)</li><li>Région de Bruxelles-Capitale</li></region><settlement><li>Bruxelles</li><li>Londres</li><li>Toulouse</li></settlement></list><tree><country name="France"><region name="Occitanie (région administrative)"><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></region></country><country name="États-Unis"><region name="Floride"><name sortKey="Zesiewicz, Theresa" sort="Zesiewicz, Theresa" uniqKey="Zesiewicz T" first="Theresa" last="Zesiewicz">Theresa Zesiewicz</name></region><name sortKey="Asgharnejad, Mahnaz" sort="Asgharnejad, Mahnaz" uniqKey="Asgharnejad M" first="Mahnaz" last="Asgharnejad">Mahnaz Asgharnejad</name></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Chaudhuri, K Ray" sort="Chaudhuri, K Ray" uniqKey="Chaudhuri K" first="K Ray" last="Chaudhuri">K Ray Chaudhuri</name></region></country><country name="Allemagne"><noRegion><name sortKey="Surmann, Erwin" sort="Surmann, Erwin" uniqKey="Surmann E" first="Erwin" last="Surmann">Erwin Surmann</name></noRegion><name sortKey="Bauer, Lars" sort="Bauer, Lars" uniqKey="Bauer L" first="Lars" last="Bauer">Lars Bauer</name><name sortKey="Nilius, Sigrid" sort="Nilius, Sigrid" uniqKey="Nilius S" first="Sigrid" last="Nilius">Sigrid Nilius</name></country><country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Dohin, Elisabeth" sort="Dohin, Elisabeth" uniqKey="Dohin E" first="Elisabeth" last="Dohin">Elisabeth Dohin</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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