Restless Legs Syndrome

By Malcolm P. Berger, M.D.

Monday, July 19, 2004



Carbamazepine 1983 RCT

3/6 patients felt better

Carbamazepine 1984 RPCT

Strong placebo effect, but carbamazepine effective. Low hemoglobin predicted worse RLS

Clonazepam 1984 RCT

Some benefit

Clonazepam 1986 CT

Little better than placebo

Clonazepam 1989 PCT

9/10 patients with renal insufficiency responded to clonazepam

Clonazepam 2001 CS

Helped patients with PLMS to sleep better. Did not help RLS patients very much.

Clonidine 1996 RCT

Helps patients to sleep, but no change in PLMS

Dopaminergics 1986 CS

Patients responded to levodopa, bromocryptine

Gabapentin 1997 CS

4/8 patients improved

Gabapentin 2001 CS

Patients improved with gabapentin.

Gabapentin 2001 PCT

11/13 hemodialysis patients responded to gabapentin, 200-300 mg post dialysis

Gabapentin 2002 RCT

At a dose of 1200-1800 mg/d, RLS symptoms are relieved, and PLMS are also reduced

Gabapentin vs ropinirole 2003 RCT

Equally effective, with long term tolerability.

Iron iv 2004 PCT

Short duration (2-4 week) response in uremic patients with RLS

Levodopa 1986 PCT

17/20 patients preferred levodopa with complete relief of symptoms

Levodopa 1988 CS

Patients responded to levodopa; the restlessness while awake seemed to have a periodicity, suggesting that RLS and PLMS are two manifestations of the same disorder

Opioids 1986 CT

Relieved RLS in 5 patients

Oxycodone 1993 RCT

Very effective at 15 mg hs; also relieves PLMS

Pergolide 1998 CS

Patients who failed levodopa responded to pergolide

Pergolide 1998 RPCT

Improved RLS during the day and PLMS during the night

Pergolide 1999 RCT

Effective at an average of 0.5 mg/d, but required domperidone.

Pramipexole 1998 CS

19/23 patients improved.

Pramipexole 1999 RCT

Most effective agent so far.

Pramipexole 2000 CS

Patients had excellent responses at doses from 0.25-0.75 mg/d

Pramipexole 2003 RCT

Long term effectiveness, with 33% requiring increased dose over 2 years. 18% dropout rate

Pramipexole 2004 CS

Rapid improvement, well tolerated

Pramipexole 2004 CS

Over time, dose often must be escalated to maintain benefit.

Ropinirole 1999 RCT

0.25 mg hs effective

Ropinirole 2004 RCT

Effective by 1 week. 23% dropout rate.

Sinemet CR 2003 RCT

Regular + CR sinemet is initially helpful, but becomes complicated by daytime problems and is discontinued by 60% of patients within 1 year

Tramadol 1999 RCT

50-150 mg/d improved 10/12 patients

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