METHODS FOR TREATING PARKINSON'S DISEASE
Methods for restoring normal patterns of activity in a subject suffering from Parkinson's Disease are disclosed that include administering an effective steady state concentration of a dopamine modulating compound continuously for a prolonged period of time such that normal patterns of activity are substantially restored in the subject.
1 . A method for restoring normal patterns of activity or for increasing on time in a subject suffering from Parkinson's Disease comprising:
administering an effective amount of a dopamine modulating compound via an implant continuously for at least 15 days such that normal patterns of activity are substantially restored in the subject,
wherein the implant is formed via co-axial extrusion and comprises:
a core comprising the dopamine modulating compound and a first biodegradable polymer; and
a sheath, which is disposed about the core, comprising a second biodegradable polymer and optionally said dopamine agonist or a different dopamine agonist.
2 . (canceled)
3 . The method according to claim 1 , wherein off time is reduced in the subject.
4 . The method according to claim 1 , wherein the severity of off time symptoms are reduced in the subject.
5 . The method according to claim 1 , wherein the frequency of off time symptoms are reduced in the subject.
6 . The method according to claim 1 , wherein the incidence of motor response complications are reduced in the subject.
7 . (canceled)
8 . The method according to claim 1 , wherein there are no periods of hyperkinetic activity in the subject.
9 . The method according to claim 1 , wherein the dopamine modulating compound is administered without the side effects associated with administration by pump infusion.
10 . The method according to claim 1 , wherein the subject experiences a period of on time immediately after waking up from sleep.
11 . The method according to claim 1 , wherein sustained efficacy is achieved in the subject for greater than 30 days.
12 . The method according to claim 1 , wherein the delivery dose required to achieve the same pharmacokinetic profile as an approved orally administered dose is 1/9 or 1/18 that of the approved orally administered dose.
13 . The method according to claim 1 , wherein the subject does not experience paralysis.
14 - 15 . (canceled)
16 . The method according to claim 1 , wherein the dopamine modulating compound is delivered via a depot.
17 . The method according to claim 1 , wherein the dopamine modulating compound is co-administered with another therapy selected from dopamine metabolic inhibitors, monoamine oxidase inhibitors, dopaminergics, dopamine agonists or adenosine receptor antagonists.
18 . The method according to claim 17 , wherein the amount of the co-administered therapy administered is decreased over time.
19 . The method according to claim 18 , wherein the side effects corresponding to the co-administered therapy are reduced.
20 . The method according to claim 19 , wherein the co-administered therapy is a dopaminergic.
21 . The method according to claim 20 , wherein the dopaminergic is L-Dopa.
22 . The method according to claim 1 , wherein the dopamine modulating compound is a 4-alkylamino-2(3H)-indolone compound.
23 . The method according to claim 1 , wherein the dopamine modulating compound is selected from bromocriptine, pergolide, pramipexole, ropinirole, piribedil, cabergoline, and lisuride
24 . The method according to claim 23 , wherein the dopamine modulating compound is ropinirole.
25 . A method for the treatment of Parkinson's Disease in a subject in need thereof comprising, administering a continuous delivery of ropinirole for at least 15 days via an implant, in combination with L-Dopa, wherein on time is increased and off time is decreased,
wherein the implant is formed via co-axial extrusion and comprises:
a core comprising the dopamine modulating compound and a first biodegradable polymer; and
a sheath, which is disposed about the core, comprising a second biodegradable polymer and optionally said dopamine agonist or a different dopamine agonist.
26 . The method according to claim 25 , wherein the subject is capable of normal activity during sleep.
27 . The method according to claim 25 , wherein the subject patient is capable of normal movement continuously.
28 . The method according to claim 25 , wherein the dopamine modulating compound is administered such that normal patterns of activity are substantially restored in the subject immediately after waking up from sleep.
29 . The method according to claim 25 , wherein the dopamine modulating compound is administered such that normal patterns of activity are substantially restored in the subject for at least 18 hours per day.
30 . The method according to claim 25 , wherein the Parkinson's Disease is mild to moderate Parkinson's Disease.