Combination preparations comprising bifeprunox and a dopamine agonist

1. A composition comprising (i) from 0.01 mg/kg to 4 mg/kg of bifeprunox or its N-oxide:

or at least one pharmacologically acceptable salt thereof, (ii) L-DOPA, or at least one pharmacologically acceptable salt thereof, and (iii) a decarboxylase inhibitor chosen from carbidopa and benserazide, for simultaneous, separate or sequential use in therapy of at least one disorder requiring recovery of dopaminergic function.

2. A composition as claimed in claim 1 , further comprising a catecholamine-O-methyltransferase inhibitor.

3. A composition as claimed in claim 2 , wherein the catecholamine-O-methyltransferase inhibitor is chosen from entacapone, nitecapone and tolcapone.

4. A composition as claimed in claim 1 , further comprising an monamine oxidase-B inhibitor.

5. A composition as claimed in claim 4 , wherein the monamine oxidase-B inhibitor is chosen from deprenyl, (−)-deprenyl, desmethyldeprenyl, N-propargyl-1-(R)-aminoindan, phenelzine, tranyl-cypromine, CGP3466, furazolidone, isocarboxazid, pargyline, methyclothiazide and procarbazine.

6. A method for manufacturing a medicament for treating at least one disorder requiring recovery of dopaminergic function, said method comprising preparing a composition comprising (i) from 0.01 mg/kg to 4 mg/kg of bifeprunox or its N-oxide:

or at least one pharmacologically acceptable salt thereof, (ii) L-DOPA or at least one pharmacologically acceptable salt thereof, and (iii) a decarboxylase inhibitor chosen from carbidopa and benserazide.

7. The method as claimed in claim 6 , wherein said at least one disorder is Parkinson's disease.

8. The method as claimed in claim 6 , wherein said at least one disorder is restless leg syndrome.

9. A pharmaceutical composition comprising, at least one of a pharmaceutically acceptable carrier and a pharmaceutically acceptable auxiliary substance, and a pharmacologically active amount of a composition comprising (i) from 0.01 mg/kg to 4 mg/kg of bifeprunox or its N-oxide:

or at least one pharmacologically acceptable salt thereof, (ii) L-DOPA or at least one pharmacologically acceptable salt thereof and (iii) a decarboxylase inhibitor chosen from carbidopa and benserazide.

10. A method for treating Parkinson's disease or restless leg syndrome, in a human or animal patient in need of such treating, said method comprising administering to the patient simultaneously, separately or sequentially, from 0.01 mg/kg to 4 mg/kg of bifeprunox or its N-oxide, or at least one pharmacologically acceptable salt thereof, a therapeutically effective amount of L-DOPA or at least one pharmacologically acceptable salt thereof, and a therapeutically effective amount of at least one decarboxylase inhibitor chosen from carbidopa and benserazide.

11. The method as claimed in claim 10 , further comprising administering a pharmacologically acceptable amount of at least one of a catecholamine-O-methyltransferase inhibitor and an monamine oxidase-B inhibitor.

12. A kit comprising:

(i) a vessel containing from 0.01 mg/kg to 4 mg/kg of bifeprunox, its N-oxide, or at least one pharmacologically acceptable salt thereof,

(ii) a vessel containing L-DOPA or at least one pharmacologically acceptable salt thereof,

(iii) a vessel containing a decarboxylase inhibitor chosen from carbidopa and benserazide, and

(iv) instructions for the sequential, separate or simultaneous administration of bifeprunox, L-DOPA, and a decarboxylase inhibitor to a patient in need thereof.

13. A method for preparing a kit comprising bringing a vessel containing (i) from 0.01 mg/kg to 4 mg/kg of bifeprunox, its N-oxide, or at least one pharmacologically acceptable salt thereof into association with (ii) a vessel containing L-DOPA or at least one pharmacologically acceptable salt thereof, and (iii) a vessel containing a decarboxylase inhibitor chosen from carbidopa and benserazide.